Effect of OM-85 BV on Wheezing Related Morbidity in Children With Recurrent Wheezing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cem Hasan Razi, Kecioren Education and Training Hospital
ClinicalTrials.gov Identifier:
NCT00733226
First received: August 11, 2008
Last updated: July 4, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to determine whether OM-85 BV (Broncho-Vaxom)has any effect on respiratory infections, infection related wheezing attacks, beta-2 agonist use, duration of attacks and effect on serum cytokine levels.


Condition Intervention Phase
Asthma
Drug: OM-85 BV (Broncho-Vaxom)
Drug: OM-85 BV (placebo)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase IV Study of Effect of OM-85 BV (Broncho-Vaxom) on Wheezing Related Morbidity in Children With Recurrent Wheezing

Resource links provided by NLM:


Further study details as provided by Kecioren Education and Training Hospital:

Primary Outcome Measures:
  • Mean Rate of Wheezing Attacks [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Acute wheezing attack was defined as episode of progressive increase in shortness of breath, cough, wheezing, retraction of the chest and chest tightness, or combination of these symptoms. When wheezing attack occured it was Over the 12 months of the study mean number (rate) of wheezing attacks/per patient was calculated and compared with placebo. This outcome measure was calculated by dividing cumulative wheezing attacks to number of participants in each group.


Secondary Outcome Measures:
  • Mean Duration (in Day) of Wheezing Attacks Per Patient [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Over the 12 months of the study we calculated mean duration of each wheezing attacks/per patients.This measure was calculated separately for each participants by dividing duration of wheezing attacks to number of wheezing attacks.

  • Number of Common Cold [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    All the common colds were recorded during the 12 months of the study. At the and of the study period the two groups were compared according to the number of common-cold/per patient over the 12 months of the trial.

    This outcome was calculated by dividing cumulative number of common colds by number of participants in each group over the 12 months of the trial.


  • Number of Wheezing Attacks That Required Systemic Steroid Therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    All the wheezing attacks which were enough severe to require systemic steroid therapy were recorded over the 12 months of the study.

    At the and of the study period, number of wheezing attacks that required systemic steroid therapy/per patients were calculated. This outcome was calculated by dividing cumulative number of wheezing attacks that required systemic steroid therapy by number of participants in each group.


  • Number of Hospitalizations [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    During the study period of 12 months all hospitalizations for wheezing attacks were recorded.

    Over the 12 months of the trial mean number of hospitalizations/per patients were calculated.

    This outcome was calculated by dividing cumulative number of hospitalizations by number of participants in each group over the 12 months of the trial.


  • Duration of Hospitalization/Per Patient [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Over the 12 months of the study we calculated mean duration of hospitalization/per patients.

  • Effect of OM-85 BV on Cytokine Levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Cytokine levels were not measured during the trial because of unavailability of laboratory resources.


Enrollment: 80
Study Start Date: August 2007
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Broncho-Vaxom
The children received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months.
Drug: OM-85 BV (Broncho-Vaxom)
3.5 mg capsule, 1 capsule per day for first 10 day of the month, for 3 months
Other Name: Bronchovaxom 3.5 mg capsule
Placebo Comparator: 2 (Placebo OM-85 BV)
The children received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
Drug: OM-85 BV (placebo)
3.5 mg oral placebo capsule, 1 placebo capsule per day for first 10 days of the months for 3 months
Other Name: Bronchovaxom 3.5 mg placebo capsule

Detailed Description:

Context: Respiratory infections are the major cause of wheezing attacks in children with recurrent wheezing or asthma in preschool age. OM-85 BV is an bacteria lysate which has been proven to prevent respiratory infections about 40 percent in children.

Objective: To determine if using OM-85 BV diminish the number and duration of the respiratory infections and respiratory infection related wheezing attacks,beta-2 agonist and steroid use, and number and duration of hospitalizations in children with recurrent wheezing and asthma. And also to determine if OM-85 BV has any effect on serum cytokine levels after 6 months.

Study Design/Setting/Participants: A double-blind, randomized, controlled trial of OM-85 BV versus placebo for children 6 months to 6 years of age who have respiratory tract infection related recurrent wheezing attacks.

Intervention: Participants will receive either active Broncho-Vaxom or placebo for 3 months.

Study Measures: They follow up for 1 year for number and duration of wheezing attacks, number, type and duration of respiratory infections, number and duration of beta-2 agonist use, number and duration of steroid use and number and duration of hospitalizations. Serum cytokine levels will measure to determine if Broncho-Vaxom has any effect on serum cytokine levels (at the beginning of the trial and sixth months of the trial).

  Eligibility

Ages Eligible for Study:   6 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children with recurrent wheezing who had at least 3 wheezing attacks in the last 6 months
  • Children with asthma who had at least 3 wheezing attacks in the last 6 months

Exclusion Criteria:

  • Chronic lung disease
  • Immun deficiency
  • Malabsorption
  • Anatomic abnormalities of the respiratory tract
  • Gastroesophageal reflux disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733226

Locations
Turkey
Kecioren Education and Training Hospital
Ankara, Kec.oren, Turkey, 06380
Keçiören Education and Training Hospital
Ankara, Keçiören, Turkey, 06380
Sponsors and Collaborators
Kecioren Education and Training Hospital
Investigators
Study Director: C H RAZI, MD Kecioren Education and Training Hospital
Principal Investigator: C H Razi, MD Kecioren Education and Training Hospital
  More Information

Publications:
Responsible Party: Cem Hasan Razi, MD, Kecioren Education and Training Hospital
ClinicalTrials.gov Identifier: NCT00733226     History of Changes
Other Study ID Numbers: B100İEG0110001 - 2860
Study First Received: August 11, 2008
Results First Received: December 16, 2009
Last Updated: July 4, 2014
Health Authority: Turkey: Ethics Committee
Turkey: Ministry of Health

Keywords provided by Kecioren Education and Training Hospital:
wheezing
asthma
childhood
OM-85 BV
Broncho-Vaxom

Additional relevant MeSH terms:
Broncho-Vaxom
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014